Posted by Mike Havrilla on Fri, Jan 08, 2010 @ 07:59 AM
On 1/7/10, the FDA granted marketing clearance to Cytori Therapeutics (NASDAQ: CYTX) for the PureGraft System, which will be launched as the first and only device in the US cleared for aesthetic body contouring using autologous (patient-derived) fat (including both small / large volumes, ranging from 50 to 250mL) and allows a patient's own fat tissue to rapidly be prepared in about 15 minutes for re-injection and aesthetic contouring. Cytori expects to launch PureGraft in the US during 1Q10 with a formal launch at the American Society of Aesthetic Plastic Surgeons in May 2010. Marketing approval (CE Mark) is pending in Europe and expected during 1H10.
On 5/27/09, Cytori announced that it completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, was carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment. The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo controlled, dose escalation study. The primary objectives of the study were to assess safety and feasibility of Cytori's Celution System as part of a novel procedure for chronic heart disease.
The Company believes it will be able to fully assess these primary objectives with the data obtained from 27 patients (the protocol allowed for up to 36 patients). Further, the independent data safety and monitoring board had not identified any safety concerns relating to the Celution output or the procedure. Six month results are expected during 1H10. On 5/28/09, Cytori announced the publication of the first preclinical study to demonstrate ADRCs significantly improved cardiac function after a heart attack. The APOLLO study is the first clinical trial to investigate uncultured adipose-derived stem and regenerative cells in heart attacks in human patients. Enrollment was recently completed in APOLLO, a double blind, placebo controlled, safety and feasibility trial. Data from this study is expected to be reported during 1Q10.
PureGraft video / product demo:
http://www.cytoritx.com/VideoPopup.aspx?link=puregraft.swf
Disclosure: Long CYTX
Posted by Mike Havrilla on Thu, Dec 31, 2009 @ 08:47 AM
A preclinical research paper recently appeared in the European Journal of Cardiology comparing freshly isolated (non-cultured) human adipose-derived regenerative cells (ADRCs) to cultured human adipose-derived stem cells (ADSCs) in a myocardial infarction (heart attack) model. The study, which was performed independently of Cytori, concluded the following:
1.) Both human cell populations improve cardiac function compared to control in a preclinical model;
2.) Improved function from ADRCs is associated with increased neovascularization, reduction in apoptosis, and production of paracrine growth factors (consistent with Cytori's findings); and
3.) The authors note the advantage of ADRCs over ADSCs is that cell culture isn't needed, thus enabling immediate or real-time cell delivery with the patient's own cells.
For more information on this paper, here's a link to the abstract (and instructions for accessing the full paper):
http://eurheartj.oxfordjournals.org/cgi/content/abstract/ehp568v1.
Posted by Mike Havrilla on Mon, Nov 16, 2009 @ 08:10 PM
Nov. 16 (Bloomberg) -- Mark Saad, chief financial officer of Cytori Therapeutics, talks with Bloomberg's Pimm Fox about the outlook for his company and regenerative medicine. Cytori has developed a device which processes fat removed from a patients body and isolates a mixture of regenerative cells.
http://www.youtube.com/watch?v=5JRwHPviBU0
Posted by Mike Havrilla on Tue, Nov 10, 2009 @ 03:19 PM
Click on the link below for an interview by Cytori's CEO Chris Calhoun with Dr. Akita from Nagasaki University and his work in radiation injury using adipose-derived stem and regenerative cells.
http://www.cytoritx.com/interview-drakita.aspx.
Posted by Mike Havrilla on Thu, Oct 22, 2009 @ 08:07 AM
Cytori Therapeutics, Inc., (NASDAQ: CYTX) will present and provide a webcast of its corporate presentation at the 2009 BIOCOM Investor Conference at 1:00 PM EDT on Tuesday, October 27, 2009.
The audio-visual webcast may be accessed under "Webcasts" in the Investor Relations section of the Company's website, www.cytoritx.com. The webcast will be available both live and by replay one hour after the presentation on the company's website. The webcast will be archived for 6 months.
Cytori has released an important Celution®800/CRS operating system upgrade, which improves performance and ease of operation. The upgrade broadens the potential number of procedures which may be performed using the Celution® System, shortens processing times, and improves the economics for our customers' practices. We expect this to accelerate the growth of our customer base and contribute to increased consumable usage.
The new software, v2.0 CRS, will increase the maximum volume of tissue which may be processed by about 40%. The volume increase will enable the device to more flexibly handle procedures that may require a greater number of cells and graft tissue, such as breast augmentation. Additionally, the software upgrade will reduce the processing time on average by 25%, increasing workflow efficiency in the operating room or clinic and reducing related costs.
V2.0 CRS will be installed as the standard operating system on all new systems and will be available as an option for our existing Celution® System customers. This development reflects Cytori's ongoing commitment to continuously improve the performance of the Celution® platform and respond to our customers' needs and feedback.
Posted by Mike Havrilla on Wed, Oct 14, 2009 @ 03:20 PM
Click on the link below for a video interview with Dr. Calabria discussing adipose-derived stem cells and face lifts:
http://extratv.warnerbros.com/2009/10/lifechangers_rejuvenate_stem_cells_face_lift.php
Posted by Mike Havrilla on Tue, Oct 13, 2009 @ 07:52 AM
On 5/27/09, Cytori Therapeutics (NASDAQ: CYTX) announced that it completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, was carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment. The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo controlled, dose escalation study. The primary objectives of the study were to assess safety and feasibility of Cytori's Celution System as part of a novel procedure for chronic heart disease. The Company believes it will be able to fully assess these primary objectives with the data obtained from 27 patients (the protocol allowed for up to 36 patients). Further, the independent data safety and monitoring board had not identified any safety concerns relating to the Celution output or the procedure. Six month results are expected during 1H10.
On 5/28/09, Cytori announced the publication of the first preclinical study to demonstrate ADRCs significantly improved cardiac function after a heart attack. The APOLLO study is the first clinical trial to investigate uncultured adipose-derived stem and regenerative cells in heart attacks in human patients. Enrollment was recently completed in APOLLO, a double blind, placebo controlled, safety and feasibility trial. Data from this study is expected to be reported during 1Q10.
On 9/9/09, Cytori announced its fall medical conference presentation schedule, including the San Antonio Breast Cancer Symposium (December 9-13) presentation of (1) interim, rolling six-month results on patients from the RESTORE-2 study and (2) preclinical data will be presented on the mechanisms by which ADRCs safely enhance fat grafting. Cytori expects to present six-month data for 15-30 patients while final, 12-month data on all patients is expected in early 2011. The ClinicalTrials.gov identifier is NCT00616135 for the RESTORE-2 study, which is a European study designed to evaluate the transplantation of ADRC-enhanced autologous (patient-derived) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.
Later this week, data from an investigator-initiated (Dr. Yamamoto, Nagoya University) study evaluating ADRCs for the treatment of stress urinary continence (SUI) is scheduled to be presented at the 7th Annual Meeting of the International Federation for Adipose Therapeutics and Science (IFATs 2009, October 15-17 in Korea). I will upload and share any details or presentation files for this data such as the study abstract after the event if possible. Also, Cytori expects to clarify the FDA medical device regulatory path for the Celution 700 System (e.g. 510k or PMA) early next year.
Posted by Mike Havrilla on Thu, Oct 08, 2009 @ 04:48 PM
Below is a link to the BBC news video:
http://news.bbc.co.uk/2/hi/uk_news/wales/8292822.stm
Posted by Mike Havrilla on Sat, Oct 03, 2009 @ 09:07 AM
Cytori has launched a new European website at
http://www.cellenrich.eu/ to help educate and raise awareness amongst patients and physicians on cell-enriched cosmetic surgery procedures.